Mechanical Engineer
3 weeks ago
Mechanical Engineer (Contract)
RESPONSIBILITIES
- Developing, implementing, and continuously improving manufacturing processes to enhance yield, reduce costs, and improve productivity.
- Representing Process Engineering in R&D and Project Team meetings, providing technical expertise in technology transfers, analytical method development, validation, and process scale-up.
- Conducting or managing process validations (IQ/OQ, OQ, PQ).
- Troubleshooting production line issues related to yield, quality, and throughput.
- Leading scaling up processes from development to full-scale manufacturing.
- Supporting evaluation of NCMR, CAPA, SCAR, Failure Investigation, and Deviation requests from Contract Manufacturers/Suppliers.
- Creating/updating manufacturing instructions, routings, bills of materials, and SOPs.
QUALIFICATIONS
- Minimum 4-5+ years of experience of medical device manufacturing.
- Experience with Design Transfer and Process Validations at external suppliers (CMO).
- Write and execute associated validations.
- Strong analytical and problem-solving skills (DOE, SPC, Six Sigma)
- Knowledge on Class II/Class III medical device manufacturing and related quality system regulations.
- Demonstrates ability to consistently meet proposed timelines, applying competent use of project planning and project management skills.
- Excellent oral and written communication skills; ability to communicate with technical and non-technical audiences.
- Ability to effectively provide direction and support to external partners/suppliers.
- Experience with electromechanical assemblies is preferred
- Design for Manufacturing experience is preferred.
- Fixture development experience is preferred.
- Experience in early stage of product development is preferred.
EDUCATION
- Bachelors in Biomedical, Manufacturing, Mechanical Engineering, or related life sciences discipline
- Six Sigma Certification.
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